image/svg+xmlRevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021125REVISTA DE PATOLOGÍA RESPIRATORIAVolumen 24 • Número 4 • Octubre-Diciembre 2021ORIGINAL ARTICLEPIMA Study. Improvement of adherence and quality of life of obstructive sleep apnea under CPAP treatment through an intervention based on the stratifcation and personalization of care plans: a randomized controlled trialD. Rudilla1, S. Perelló2, P. Landete3, E. Zamora3, M. Vázquez4, Ll. Sans2, J.M. Tomás5, G. Rubinos4,*, J. Ancochea3,*1Air Liquide Healthcare – Hospital Universitario de La Princesa. Madrid, Spain. 2Hospital Universitario Joan XXIII. Tarragona, Spain. 3Hospital Universitario de La Princesa. Madrid, Spain. 4Hospital Universitario Central de Asturias. Oviedo, Spain. 5University of Valencia. Valencia, Spain. *Shared last authorship.Rev Patol Respir. 2021; 24(4): 125-134Correspondencia:David Rudilla, PhD. C/ Orense, 34, 3-1. 28004 Madrid (Spain). E-mail: david.rudilla@airliquide.com Recibido: 29 de octubre de 2021; Aceptado:22 de diciembre de 2021AbstractIntroduction. The frst-line treatment for obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP) therapy. Lack of adherence is the main problem with CPAP. A motivated patient is needed. The objective of this study is to determine adherence to CPAP and health-related outcomes in patients with OSA through a comprehensive program based on stratifcation and individualized care plans, using motivational interviewing.Methods. Multicenter randomized controlled trial (RCT) conducted in 3 hospitals. Control group followed the usual treatment. Intervention group (PIMA) followed the treatment with an adapted care based on sociodemographic, clinical and psychological variables, using motivational interview. The main outcome was adherence (90 and 180 days of treatment), and the secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence, and motivation.Results. 213 patients were randomized (intervention group: 108; control group: 105). A statistically signifcant difference was found in the intervention group versus the control group in adherence at 90 and 180 days: 129.24 (IC95% 77.25-181.22) p< 0.0001 and 288.30 (IC95% 187.146-389.47) p< 0.0001. Adherence (hours/day) was higher in the PIMA group compared to the control group at 90 days with a difference of 1.74 hours/day (IC95% 1.18-2.30) p< 0.0001 and at 180 days with a dif-ference of 2.31 (IC95% 1.72-2.91) p< 0.001. The secondary results showed signifcant differences in favour of the PIMA group.Conclusions. Evidence was found that a program based on stratifcation and personalized care plans, using motivational interviewing, improves adherence to CPAP and quality of life.Key words:Adherence; CPAP; Quality of life; RCT; Obstructive sleep apnea; Stratifcation.ESTUDIO PIMA. MEJORA DE LA ADHERENCIA Y DE LA CALIDAD DE VIDA DE LA APNEA OBSTRUCTIVA DEL SUEÑO EN TRATAMIENTO CON CPAP A TRAVÉS DE UNA INTERVENCIÓN BASADA EN LA ESTRATIFICACIÓN Y PERSONALIZACIÓN DE LOS PLANES DE ATENCIÓN: UN ENSAYO CONTROLADO ALEATORIZADOResumenIntroducción. El tratamiento de primera línea para la apnea obstructiva del sueño (AOS) es la terapia de presión positiva continua en las vías respiratorias (CPAP). La falta de adherencia es el principal problema de la CPAP. Se necesita un paciente motivado. El objetivo de este estudio es determinar la adherencia a la CPAP y los resultados relacionados con la salud en pa-cientes con AOS a través de un programa integral basado en estratifcación y planes de atención individualizados, utilizando entrevista motivacional.Métodos. Ensayo controlado aleatorizado multicéntrico realizado en 3 hospitales. El grupo de control siguió el tratamiento habitual. El grupo de intervención (PIMA) siguió el tratamiento con un plan de cuidados adaptado basado en variables socio-demográfcas, clínicas y psicológicas, utilizando entrevista motivacional. El resultado principal fue la adherencia (90 y 180 días de tratamiento) y los secundarios fueron la calidad de vida, el estado emocional, las actividades, las relaciones sociales, la competencia percibida y la motivación.Resultados. Se aleatorizaron 213 pacientes (grupo PIMA: 108; grupo de control: 105). Se encontró una diferencia estadís-ticamente signifcativa en el grupo PIMA versus el grupo control en la adherencia a los 90 y 180 días: 129.24 (IC95% 77.25-181.22) p < 0.0001 y 288.30 (IC95% 187.146-389.47) p < 0.0001. La adherencia (horas/día) fue mayor en el grupo PIMA
image/svg+xml126RevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021Introduction Obstructive sleep apnea (OSA) is a common sleep dis-order, characterized by repeated pauses in breathing during sleep. It is a chronic condition affecting nearly one billion adults worldwide, with nearly half requiring treatment based only on OSA severity1. OSA is defned by the presence of at least fve obstructive respiratory events per hour of sleep and the presence of symptoms such as daytime sleepiness, snoring, witnessed breathing interruptions, awakenings due to gasping or choking, resistant hypertension, or reduced sleep- related quality of life2. Daytime sleepiness is often prioritized due to immediate safety risks, as individuals with untreated OSA are 243% more likely to have a motor vehicle accident than drivers without OSA3. In addition to excessive daytime sleepiness4and increased risk of mo-tor vehicle accidents5, untreated OSA is associated with additional adverse daytime symptoms including impaired cognitive performance6, and mood disturbances7. It is also associated with negative health consequences, including car-diovascular disease and hypertension8, diabetes9, stroke10, and death11. ContinuePositive airway pressure (CPAP) ther-apy is an effcacious treatment for OSA12. CPAP treatment is behaviourally based and requires the individual with OSA to wear PAP every night. Most research considers a patient who uses CPAP a minimum of 4 hours a night during 70% of the week to be a good complier13. Multidisciplinary approaches based on the study of behavioural changes together with continuous monitoring have shown promising results in im-proving patient adherence to CPAP intervention14,15. Patients may beneft from more individualized treatment, which can be done by reducing the risk of OSA consequences on a patient-to-patient basis.Motivational interviewing (MI) is a technique that involves discussing treatment with patients in a way which empowers them to understand their individual therapy needs and drive them to address those. Different studies have demonstrated the usefulness of MI in the CPAP treatment of sleep ap-nea16,17. Therefore, it is very likely that MI, in combination with personalized patient interventions, could further improve adherence.The main aim of this study is to determine whether OSA patient adherence to CPAP can be improved using a compre-hensive, multidisciplinary programme, based on a motiva-tional change model and integration of predictive factors of adherence, to obtain a specifc patient profle and therefore a personalized intervention plan. Secondary objectives were to improve quality of life, emotional state, activities, social relationships, perceived competence, and motivation.Materials and methods DesignA multi-centre randomized, controlled trial (RCT) design was used, enrolling adult patients with OSA and a prescrip-tion for CPAP treatment from the Respiratory Medicine De-partment at La Princesa University Hospital (Madrid, Spain), Joan XXIII University Hospital (Tarragona, Spain) and Central University Hospital of Asturias (Oviedo, Spain), between May 2018 and June 2019. The study protocol was approved by the Clinical Research Ethics Committee at the participating hospitals (N. 3450; N96/19). The clinical trial was registered with www.clinicaltrials.gov (NCT 04691479). PatientsThe subjects enrolled in the study were required to have a diagnosis of OSA confrmed by sleep studies with polygra-phy and/or polysomnography (criteria of the Spanish Sleep Society) and be naive to CPAP intervention. The study ex-cluded subjects with obesity-related hypoventilation, severe COPD, cognitive disorders and those unable to understand the consent to participate. Prior to enrolment in the study, all patients were informed in detail about the study and signed the consent form to participate. The subjects enrolled in the study had to have a diagnosis of OSA confrmed by sleep studies with polygraphy and/or polysomnography (criteria of the Spanish Sleep Society) and be new to the CPAP intervention. The study excluded subjects with obesity-related hypoventilation, severe COPD, cognitive disorders, and those who could not understand consent to participate. Before enrolment in the study, the pulmonolo-gists informed the patients in detail about the study, signing the specifc consent form if they agreed to participate.InterventionsA process was followed using a random number generator in SPSS to systematically assign patients to one group or another, with allocation concealment. The prescribers se-quentially included the patients in a spreadsheet that auto-matically and randomly assigned the patient to the group according to the algorithm generated by SPSS. See Figure 1.Control group patients followed the standard of care. This standard is set by the Guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR)19. Once the prescription reached the nurse, she would call the patient to carry out the patient education and training process, which included the use of CPAP equipment, mask ftting, safety and maintenance. For follow-up, the patient always went to the specialized follow-up consultation located in the hospital. The comparado con el grupo control (90 días) con una diferencia de 1.74 horas/día (IC95% 1.18-2.30) p < 0.0001 y a los 180 días con una diferencia de 2.31 (IC95% 1.72-2.91) p < 0.001. Los resultados secundarios mostraron diferencias signifcativas a favor delgrupo PIMA.Conclusiones. Se encontró evidencia de que un programa basado en estratifcación y planes de atención personalizados, utilizando entrevistas motivacionales, mejora la adherencia a la CPAP y la calidad de vida.Palabras clave: Adherencia; CPAP; Calidad de vida; RCT; Apnea obstructiva del sueño; Estratifcación.
image/svg+xmlRevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021127frequency of visits was days 30, 90 and 180 from the start of therapy. The follow-up procedure consisted of reviewing the CPAP hour meter and resolving any incidents themselves, with the necessary corrective actions. The nurses were spe-cialized in CPAP treatment, with experience between 1 and 2 years. They did not receive any special training in com-munication skills.The patients assigned to the intervention group ‘PIMA’ (Spanish acronym: Individualized Adherence Improvement Plan; Personalized Adherence Improvement Plan) were sum-moned by the nurse to start therapy once the prescription was received. The intervention had 4 steps: a) Stratifcation to identify the patient’s profle, b) Health education and train-ing, c) Evaluation of predictive variables of adherence and d) Follow-up according to individualized plan.Stratifcation to identify the patient’s profleThe objective of stratifcation is to identify patient pro-fles to which the intervention can best be adapted. For this, certain personal variables are taken into account: age, ed-ucational level, isochrone (the time the patient needs from home to the care center), use of digital tools (email, etc.) and service preferences (home visit preferences, calls, spe-cialized center ...). The choice of these variables was made according to the bibliography15. For each variable, 4 possi-bilities were established, each corresponding to a possible type of profle: ‘a’, ‘b’, ‘c’ and ‘d’ (Table 1). Together with the patient, the nurse identifed the alternative that represented each variable. To know the fnal profle, since there could be multiple combinations, it was taken into account which possibilities were repeated the most in each of the 4 possible profles. In this way, the results are patients with profle ‘a’ (characterized by autonomy and mobility, predisposition to remote follow-up), patients with profle ‘b’ (need for moder-ate intensity in follow-up) or patients with profle ‘c’ (more mobility diffculties and require more intensive treatment). Profle ‘d’ was applied to patients who were professional drivers, as they require specifc interventions based on their occupation. At this time, the nurse also collected two clini-cal variables: AHI (it was taken from the patient’s medical history) and administered the Epworth Sleepiness Scale19.Health education and trainingThe intervention for health training and education con-sisted of the application of the MEntA (Motivational Interview for Adherence) program17. This program consists of the ap-plication of the MI communication technique to the training of the patient in the treatment of CPAP. For this, the nurses were trained in MI by a clinical psychologist before starting the study. MEntA is applied in 2 parts: a part focused on promoting disease awareness and preparing the patient to show willingness and interest in treatment, and a second part focused on the use of the device, mask ft, maintenance and safety. All the materials used (presentation slides, guides and manuals…) were adapted to a motivational language. The duration of this process consisted of 45-55 minutes.Evaluation of predictive variables for adherenceAfter training, the nurse evaluated, on the one hand, the degree of motivation of the patient towards the therapy and her perceived competence or self-effcacy. To know the state of motivation, the categorization defned in the trans-theoretical model of Prochaska and DiClemente20was used, with a question open to the patient (“After everything we have explained to you, how motivated do you feel to start and follow CPAP treatment?”) that could be classifed into fve states: pre-contemplation (very low motivation), con-templation (low motivation), determination (somewhat mo-Figure 1.Descriptive diagram of the interventions.MEntA:Educational and Training RandomizedTraining Program Follow-up scheduling– Stratification: identify the patient's profile– Assessment of predictive variables of adherence PIMA group Control group – Frequency: D30-D60-D90-D180-D365– Channel: Home / Care center / Phone / Telemonitoring– Action: Adherence evaluation (Compliance + Epworth + Perceived Competence + Social Support + Quality of Life)Follow-up according to individualized plan– Frequency: D30-D90-D180-D365– Channel: Care center– Action: Adherence evaluation (Compliance)– Corrective actions– Positive reinforcement Follow-up according to Standard of Care plan
image/svg+xml128RevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021tivated), active change (quite motivated) and maintenance (high motivation). Regarding the evaluation of perceived competence, the Validated Perceived Competence Assess-ment Questionnaire in Adherence to CPAP in OSA (CEPCA) was used21. The nurse took into account the set of variables (motivation, perceived competence, OSA severity and symp-toms), to ‘predict’ what would be the patient’s adherence at the start of CPAP therapy. Patients with moderate or high motivation, a good perception of self-effcacy and signifcant symptoms were interpreted as a potential high adherence, and patients with low motivation and poor perception of self-effcacy were interpreted as risk of low adherence. Those patients who had only low motivation or only low self-effcacy were considered to have moderate adherence.Follow-up according to individualized planWith the identifcation of the patient’s profle and possible level of adherence at the beginning of therapy, the individ-ualized plan to improve adherence was assigned. Each plan takes into account how the patient is and depending on how the level of adherence is, the type of intervention necessary (Table 1). In the follow-up visits (which depended on the previous state of adherence and the patient’s profle), the nurse reviewed the variables of motivation and self-effcacy, in addition to adherence. After the review, the next visit was indicated (depending on the level of adherence and profle). Every time a patient presented low adherence, an intensive follow-up process with telemonitoring was started. This confguration allows, on the one hand, the dedication of resources to patients who need more care, and on the other hand, the long-term management of large volumes of patients.Several outcomes were included in this study. First, ad-herence (number of hours of CPAP use/per night) to CPAP treatment after 90 and 180 days of treatment was assessed as the primary outcome. The total number of night hours during which the CPAP device was used at therapeutic pres-sure was recorded by specifc counters within each device and collected during the study follow-up period. In terms of secondary outcomes, quality of life was assessed using the Apnea Analog Visual Well-Being Scale22(0 is ‘Least favour-able well-being status’and 10 is ‘Most favourable well-be-ing status’) and sleepiness was assessed using the Epworth Sleepiness Scale19. Motivation, as defned in the transthe-Table 1.PIMA Care plans: profle, level of adherence and general interventions.ProfleHigh adherenceModerate adherenceLow adherenceaChannels:Phone-callFrequencies:*– Day 30, Day 90– After 90 days: Every 6 monthsContents:Positive motivational reinforcementChannels:Phone-call & Care CenterFrequencies:– Day 30, Day 60, Day 90– After 90 days: Every 90 daysContents:Motivational interview, functional analysisChannels: Phone-call & Care CenterFrequencies: Every 30 days until change level of adherenceContents:Motivational interview, training and educational reinforcementTelemonitoringAge< 51 years oldLevel studiesHigh-SuperiorDigitalInternet, email, appIsochroneLess than 30 minutesPreferenceRemotebChannels:Phone-call & Care CenterFrequencies:– Day 30, Day 90– after 90 days: Every 6 monthsContents:Positive motivational reinforcementChannels:Care CenterFrequencies:– Day 30, Day 60, Day 90– After 90 days: Every 90 daysContents:Motivational interview, functional analysisChannels: Care CenterFrequencies: Every 30 days until change level of adherenceContents:Motivational interview, training and educational reinforcementTelemonitoringAgeBetween 51 and 65 years oldLevel studiesMediumDigitalInternetIsochroneBetween 30 and 60 minutesPreferenceRemote with HomecChannels:HomeFrequencies:– Day 30, Day 90– after 90 days: Every 6 monthsContents:Positive motivational reinforcementChannels:HomeFrequencies:– Day 30, Day 60, Day 90– After 90 days: Every 90 daysContents:Motivational interview, functional analysisChannels: HomeFrequencies: Every 30 days until change level of adherenceContents:Motivational interview, training and educational reinforcementTelemonitoringAgeMore than 66 years oldLevel studiesBasic-LowDigitalNoneIsochroneMore than 60 minutesPreferenceHomedChannels:Care Center (start), Phone-call (follow-up)Frequencies:– Day 30, Day 90– after 90 days: Every 6 monthsContents:Positive motivational reinforcementChannels:Care CenterFrequencies:– Day 30, Day 60, Day 90– after 90 days: Every 90 daysContents:Motivational interview, functional analysisChannels: HomeFrequencies: Every 30 days until change level of adherenceContents:Motivational interview, training and educational reinforcementTelemonitoringPatients who are professional drivers*The type of intervention will depend on the patient’s profle and their level of adherence. The patient can change their frequencies and the intervention time depending on the level of adherence they have at the time of the review. The patient can only change in the 3 possible levels of adherence of his/her profle.
image/svg+xmlRevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021129oretical model20, was also assessed by an open question to the patient, which could be classifed into the fve stages. In addition, three health-related outcomes (mood, activities, social relationships) were also measured using the following ad hoc question ‘Taking into account your sleep problems, how would you say you are in terms of mood / activities / social relationships?’. The answer alternatives were: ‘2 Good’, ‘1 Normal/no change’, ‘0 Bad’.Statistical analysisThe sample size was determined based on a previous moderate effect size of .6 taking into account literature available with similar characteristics to those proposed in this study23. As such, with an alpha value of .05 and a max-imum beta error of .20, a total number of 70 subjects were established, which was increased considerably in order to compensate for possible experimental mortality in the study and to reduce the variability of the measures being studied. A descriptive analysis of the demographic and clinical characteristics of all patients enrolled in the study was per-formed, as well as a baseline analysis comparing both study groups after randomization. The statistical inference anal-yses were performed using both parametric (t-student for independent groups) and non-parametric (U-Mann Whitney) models for continuous variables, and crosstab analysis for categorical data. The analyses were performed for the com-parison of study groups at two cut-off time points (90 and 180 days) and an ad hoc analysis at one year of follow-up for the most important variables. The Chi-square statistic was used for comparing all categories at one-year adherence analysis. The alpha value was 0.05 and all analyses were performed on two-tails. The statistical software used was SPSS V26.ResultsDescriptive statisticsOf a total of 257 eligible, 44 patients were excluded for different reasons (see Figure 2). A total of 213 patients were randomized between the two groups (PIMA and Control) of whom 108 were in the intervention group and 105 were in the control group. 68.1% were men, 58.7% of the study sample were aged between 51 and 69, and 45.5% had up-per-secondary school education. Tests performed to compare control and PIMA groups at the beginning of the RCT showed that groups were equivalent for all baseline variables. Table 2 provides descriptive characteristics of the participants.A total of 9.85% (21 subjects) withdrew from the study. The percentage of withdrawals in the PIMA group was 10.18% (11 subjects) while in the control group it was 9.52% (10 subjects). In the PIMA group, the reasons for this were: 8 subjects for clinical reasons (changes of treatment), 2 lost, 1 abandoned. In the control group, 7 patients withdrew be-cause of voluntary abandonment and 3 patients were lost. None of the withdrawals were due to possible adverse effects. Inferential statistics results The mean adherence was compared between the study groups during therapy follow-up. The result showed a statis-tically signifcant difference at 90 and 180 days respective-ly: 129.24 (IC95% 77.25 - 181.22) p< 0.0001 and 288.30 (IC95% 187.146 - 389.47) p< 0.0001. These results were also confrmed by non-parametric analysis. Also, the num-ber of hours of sleep per day indicated positive results for the study intervention compared to the control group at 90 days with an improvement of of 1.74 hours per day (IC95% 1.18 - 2.30) p< 0.0001 and at 180 days with an improve-Figure 2.Consort dia-gram of participants randomized to PIMA and Control Groups.Analysed (n=96)Analysed (n=93)Assessed for eligibility (n=257)Randomized (n=213)AllocationEnrollmentFollow-upAnalysis– Clinical reasons (n=8)– Lost (n=2)– Voluntary abandonment (n=1) Lost to follow-up (give reasons) (n=11)– Voluntary abandonment (n=7)– Lost (n=3)Lost to follow-up (give reasons) (n=10)– Received allocated intervention (n=107)– Did not receive allocated intervention (Does not attend) (n=1) Allocated to PIMA Intervention (n=108)– Received allocated intervention (n=103)– Did not receive allocated intervention (Referred to another specialist) (n=2)Allocated to Control Group Intervention(n=105) – Not meeting inclusion criteria (n=16)– Declined to participate (n=12)– Other reasons (n=8) Excluded (n=44)
image/svg+xml130RevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021Table 2. Baseline characteristics of the participants.VariableTotal sample (n= 213)PIMA group(n= 108)Control group (n= 105)TestdfPFrequency (%)Mean (SD)Frequency (%)Mean(SD)Frequency (%)Mean (SD)Sex (male)145 (68.1)72 (66)73 (69.5)0.2001.655Age by groups1.792.407< 50 years 53 (24.9)23 (21.30)30 (28.6)51-69 years 125 (58.7)65 (60.2)60 (57.1)> 70 years 35 (16.4)20 (18.5)15 (14.3)BMI by categories4.6956.584Normal weight18 (8.5)8 (7.4)10 (9.5)Overweight62 (29.1)28 (26)34 (32.4)Obesity131 (61.5)71 (65.8)60 (57.1)Missed2 (0.9)1 (0.9)1 (0.9)Severity OSA-.922211.357Mild7 (3.3)6 (5.6)1 (0.9)Moderate27 (12.7)12 (11.1)15 (14.3)Severe179 (84)90 (83.3)89 (84.8)Apnea-hypopnea index41.98 (20.28)40.71 (16.35)43.29 (23.66)Reason for consultation2.592.274Individual72(33.8)41 (38)31 (29.5)Derivation52(24.4)22 (20.4)30 (28.5)Familiar surroundings 89(41.8)45 (41.7)44 (42)Quality of life 5.24 (2.23)5.45 (2.30)5.02 (2.14)1.423211.156Comorbidity1.6943.638Physical 122 (57.3)61 (56.5)61 (58.1)Psychic 11 (5.2)4 (3.7)7 (7)None80 (37.6)43 (40)37 (35.2)Drowsiness 11.57 (5.22)11.61 (5.15)11.53 (5.31)0.108211.914Educational levels2.2772.320High-Superior41 (19.2)25 (23.1)16 (15.2)Medium 97 (45.5)48 (44.4)49 (46.7)Low75 (35.2)35 (32.4)40 (38.1)Isochrone2.0452.360< 30’196 ( 92.0)99 (91.7)97 (92.4)30-60’15 (7.0) 7 (6.5) 8 (7.6)> 60’2 (0.9)2 (1.9)(0.0)Use digital tools0.2232.895App + email + Internet137 (64.3)68 (63)69 (65.8)Internet37 (17.4)19 (17.6)18 (17.1)None39 (18.3)21 (19.5)18 (17.1)Profle4.5373.20966.7a64.868.622.5b25.020.09.4c7.411.41.4d2.80.0Mood1.4612.482Bad44 (20.7)20 (18.5)24 (22.9)Normal/no change126 (59.2)63 (58.3)63 (60)Good43 (20.2)25 (23.1)18 (17.1)Daily life activities.9772.614Bad64 (30)31 (28.8)33 (31.4)Normal/no change111 (52.1)55 (51.1)56 (53.3)Good38 (17.8)22 (20.3)16 (15.2)Social relationships.3012.860Bad39 (18.3)20 (18.5)19 (18.1)Normal/no change145 (68.1)72 (66.7)73 (69.6)Good29 (13.6)16 (14.9)13 (12.4)BMI: Body mass index.
image/svg+xmlRevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021131ment of 2.31 hours per day (IC95% 1.72 - 2.91) p< 0.001. Moreover, patients in the PIMA group showed an increase in hours of sleep per day of 0.53 (IC95% 0.032 - 1.04) p< 0.05 between days 90 and 180, whereas patients in the control group did not result in increased average sleep per day between these time points. This was also confrmed by non-parametric analysis: p < 0.01. Table 3 for complete results. See Figure 3.The secondary outcomes also showed statistically sig-nifcant improvement for the PIMA group patients for all measures evaluated. The quality of life at 90 days was 2.56 higher in the PIMA group (IC95% 2.03 - 3.08) p< 0.0001 and at 180 days was 0.20 higher (IC95% 0.74 - 1.56) p< 0.0001, see Figure 4. The patient state of mind was evaluated using three categories and showed that 73 of 102 patients (71.5%) in the PIMA group reached the best score at 90 days com-pared with only 28 of 95 patients (29.5%) in the control group p< 0.0001 at that same time point. Similar results were found for daily life activities with 63 and 33 patients reaching the best category for PIMA and control groups re-spectively p< 0.0001. The frequency of social relationships showed a statistically signifcant difference between groups at both 90 and 180 days p< 0.0001). Similar results were found for evaluation of state of mind at 180 days, indicating that 84 patients (85%) in the PIMA group reached the best score compared with 52 (53.6%) in the control group p< 0.0001. For daily life activities at 180 days the data showed that 79 out of 99 patients (80%) for PIMA group were active compared with 53 out of 97 patients (55%) in the control group p< 0.0001.It is also interesting to consider communication channels used for the patient interventions, since this will determine resources required to provide support. Thus, at 90 days the use of telephone as the main communication channel was used by 31.4% of patients in the PIMA group while 64% of this group preferred a meeting point. On the contrary, for the control group, all subjects preferred the meeting point p< 0.0001. However, after 180 days of follow up 96% of patients in the PIMA group were using the telephone as their frst communication channel compared with 0% of patients in the control group p< 0.0001. Also, the number of unsched-uled calls during the follow up showed a mean of 0.19 (SD 0.57) for the PIMA patients compared with 0.41 (0.73) those for control patients, p= 0.003 for non-parametric analysis.Table 3.Adherence results for PIMA vs control group. VariablePIMAControlp-valueNMeanSDNMeanSDAdherence 90 days101494.812158.6395365.57215.78< 0.0001Adherence 180 days97987.608312.71997699.300396.475< 0.0001Adherence h/d 90 days1025.801.63954.062.28< 0.0001Adherence h/d 180 days996.331.99974.012.23< 0.0001Change h/d 90 vs 180 days990.521.8193-0.011.73= 0.037Adherence one year 962161.71864.43871661.21887.22< 0.0001Adherence h/d one year 965.922.37874.552.43< 0.0001Quality of life one year 968.691.66867.671.59< 0.0001h/d: hours per day. SD: standard deviation. Figure 3.Adherence. Hours per day at 180 days of follow up. Figure 4.Quality of Life at 180 days. 76543Hours per day at 180 daysInterventionError Bars: 95% CIControlPMA6.334.019,59,08,58,07,57,0QoL at 180 daysInterventionError Bars: 95% CIControlPMA8.937.77
image/svg+xml132RevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021The Epworth Somnolence Scale results collected from patients after180 days a mean difference between groups of -3.12 (IC95% -3.98 to -2.26) p< 0.0001, with the a mean value of 2.03 for the PIMA group compared with 5.15 for the control group. The motivation score for the frst cut-off showed 49 patients in the PIMA group (45%) were quite motivated in contrast to 36 patients (34.2%) in the control group p< 0.001. Evaluation at day 90 showed 75 (73.5%) patients in maintenance (high motivation) in the PIMA group compared with 21 patients (22.1%) from the control group p< 0.0001. Measurement at day 180 showed an increase in maintenance patients in the PIMA group (85 patients, 85.9%), while for the control group, this fgure only increased to 25 patients (25.8%), p< 0.0001. An ad hoc analysis at one year of follow-up still showed statistically signifcant differences between the PIMA and control groups for the main variables (Tables 3 and 4). 80% of patients were compliant at day 365 in the PIMA group compared with 66.3% in the control group. The improvement in overall adherence to CPAP therapy in the PIMA interven-tion group is clearly demonstrated. At Day 365, the % of non-compliers in the PIMA and control groups were 20% and 33.7% respectively. The decrease in non-adherence can also be observed at earlier time-points during the study, where the % of non-compliers at Day 90 and D180 were 11.8% compared with 45.7% and 18.2% compared with 38.9% in the PIMA and control groups respectively. Statistically sig-nifcant differences were found in patients with adherence greater than 6 hours (t [81] = 3.505; p < .001) but not in patients with adherence between 4 and 6 hours (t [51]) = -. 156; p = .438).The largest impact of the PIMA intervention on the im-provement of adherence to CPAP therapy is observed in the group of subjects with adherence < 2h/day, more so than any higher adherence time category. This is also consistent across all time points. DiscussionThis study has found evidence that a programme based on stratifcation labels for patients to obtain personalized care plans, achieves a higher level of effcacy in adherence to the CPAP intervention, as well as an improvement in quality of life, emotional state and motivation, when compared to the standard of care intervention. The data observed in this study shows how an approach that stratifes OSA patients based on objective measurements is highly useful in determining specifc plans according to subject profles and thereby im-proves adherence with the CPAP intervention. The results obtained through clinical trials, which have been widely discussed, range from increased number of hours of sleep, quality of life and social relationships, to improve-ments in cognitive performance and reduced mortality24. However, the effcacy of CPAP interventions depends on prop-er adherence and given its specifc conditions of use. This aspect still requires a signifcant level of research, since it has been observed that, in the past 20 years, the percentage of subjects who do not manage to reach 7 hours of night-time sleep while using this intervention has remained constant at around 34% of subjects23. The results of our research show that the stratifcation procedure, based on which a personalized adherence im-provement plan is put in place, is able to maintain adherence with the therapy for up to 180 days compared to the usual practice for monitoring this type of patient undergoing CPAP intervention. The PIMA programme improves therapeutic ad-herence by raising patient awareness and adjusting care to consider changes in their lifestyle and technological ad-vances such as telemonitoring16,25,26. Previous studies have shown the importance of examination before prescription, due to the infuence of anatomical differences in terms of adherence27. It has also been observed that the success of long-term adherence is conditioned, to a large extent, by the patient’s behaviour during the frst two weeks28together with the immediate social support they receive29. Similarly, the use of new technologies, such as telemonitoring enables early intervention with alerts to complications or changes in use30. The use of telemonitoring provides benefts in terms of adherence, and it seems very useful in situations of early detection or identifcation of barriers to adherence and to certain profles that present a specifc clinical picture and specifc situation25.An important aspect is the cost-beneft impact of an in-tervention based on personalization of care. PIMA allows sustainability since with stratifcation and segmentation, it is identifed which patients need more attention, without forgetting the long-term treatment of the rest of the patients.As a patient’s pattern of adherence is evident within the frst weeks of CPAP treatment, it is highly likely that patients have already formed perceptions regarding the seriousness of OSA and the beneft of treatment, and thus these cogni-tions infuence adherence30. Education is one way to enhance self-effcacy. MEntA, the educational program used by the PIMA programme is based on the motivational interview, for which there is also extensive evidence on its effcacy in health Table 4.Compliance categories for adherence results at one yearAdherence category at day 365PIMA NControl NPIMA (%)Control (%)Difference≥ 6 h / day512953.7%34.9%18.8Adherent≥ 4 and < 6 h / day252626.3%31.3%-5Adherent≥ 2 and < 4 h / day14714.7%8.4%6.3Non-Adherent< 2 h / day5215.3%25.3%-20Non-AdherentTotal9583100%100%
image/svg+xmlRevistadePatologíaResPiRatoRiavol. 24 Nº4 - octubRe-diciembRe2021133interventions26,31. The factors which the aforementioned stud-ies determine as being predictive of proper adherence are complemented in the PIMA model by the Transtheoretical Model of Change, in its version adapted to sleep apnoea treatment, from the initial version created to predict smoking cessation32. Studies have observed that beliefs related to the pathol-ogy or effcacy of the treatment, together with the percep-tion of self-effcacy in terms of confdence in starting the treatment and in beliefs regarding proper interaction with the environment, explain an up to 30% difference in the use of the CPAP intervention33. A high level of adherence is associated with an internal locus of control31(subjects who believe they are in control of their own situation are more likely to take on board the advice provided by the physician) increasing adherence to CPAP34. Motivated patients have a higher level of adherence to CPAP35. This also applies to subjects with social support, with an improvement in sleep quality and quality of life also being observed in the person sharing a bed with the patient36. All of these predictive factors are included in the framework of the PIMA programme and were used to determine the label for each patient and the degree of personalization included to monitor them.The PIMA intervention in our study was based on a broad, multidisciplinary framework with the aim of personalizing the approach needed by each patient in terms of improv-ing adherence to CPAP. This intervention strives to change the patient’s perception of the diffculties and drawbacks of the proposed therapy, as well as their possible risks and ability to use it. To this end, these results not only show an improvement in the adherence, but also show statistically signifcant correlations between this adherence and positive correlates such as quality of life and activities. Statistically signifcant relationships were observed between adherence and patients-reported-outcomes (PROs). These variables are highly related to the effcacy of the CPAP therapy.This study has different limitations. First of all, the du-ration of it. Although the measurement of some outcomes in the long term (1 year) has been taken into account, they have not been measured or a special follow-up has been carried out between day 180 and day 365. On the other hand, although the use of digital tools has been taken into account in the patient’s profle, no intervention has been carried out that allows us to know if adapting the care plan to this situation can improve the results. In addition, the proposal of this program may have little scalability capac-ity, given that certain resources are needed (care centers, contact center...).InterpretationThe PIMA model summarizes and quantifes the most relevant aspects to be considered in caring for CPAP therapy patients. It provides a specifc profle for each patient aiming to provide personalized care with the help of new information technologies. Ultimately, this methodology improves OSA patients’ adherence to CPAP therapy, thereby improving their quality of life and everyday living conditions. Improvement in adherence to CPAP therapy leads to an overall lower burden of disease and decreased costs associated with events arising from poorly-managed OSA.AcknowledgementsThe research team would like to thank Ana Román and Jennifer Leonardi from Air Liquide Healthcare for the resources provided, as well as for reviewing the English translation of the manuscript. Also to the VitalAire healthcare staff for their involvement in the study: Verónica Motera and Patricia Rodríguez.Financial supportsThis work has not received any specifc funding from pu-blic sector agencies, commercial sector or non-proft entities.Author contributions David Rudilla, Julio Ancochea and Gema Rubinos are re-sponsible for the conceptualization of the study. In the design of the methodology, Pedro Landete, Enrique Zamora and Maria Vázquez have participated together with David Rudi-lla. Those responsible for the validation of the results have been Julio Ancochea, Salvador Perelló and Gema Rubinos. Regarding the analyses, David Rudilla and Jose Manuel Tomás have been responsible. The necessary resources have been coordinated by David Rudilla and Lluisa Sans. Regarding the manuscript, David Rudilla, Pedro Landete and María Vázquez have participated in the drafting of the draft and the revision and editing. For the fnancing, Julio Ancochea, Gema Rubinos and David Rudilla have been responsible.Conficts of interestThe authors declare that they have no confict of interest.Ethics approvalThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Clinical Research Ethics Committee of Hospital Universitario de La Princesa (N.3450) and Hospital Universitario Central de Asturias (N96/19).References 1. Benjafeld AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019; 7(8): 687- 698. 2. Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical prac-tice guideline. J Clin Sleep Med. 2019; 15(2): 335-43. 3. Purtle MW, Renner CH, McCann DA, Mallen JC, Spilman SK, Sahr SM. 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